A ProMED-mail post, (www.promedmail.org) ProMED-mail is a program of the International

Society for Infectious Diseases (www.isid.org)

[1]

Date: Fri 23 Mar 2012

Source: Top Secret Writers [edited]

(judge-forces-fda-remove-antibiotics-food-animals)

Judge forces FDA to remove approval for antibiotics in food animals

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In a major win for those fighting the cause of antibiotic resistance in humans, on 23 Mar 2012, a federal court ruled that the FDA must take action related to its 1977 safety findings regarding the dangers of antibiotic use in animals.

The court noted that today there is finally enough evidence to prove that the dangers predicted by the FDA in 1977 have been realized, and that standing on the sidelines and waiting to see whether the meat industry can police itself on the use of antibiotics is no longer an option.

The court ruling stated, “In the intervening years, the scientific evidence of the risks to human health from the widespread use of antibiotics in livestock has grown.”

In 1977, the FDA concluded based on its own research that, “Organisms resistant to antibacterial agents have been found on meat and meat products.”

This was a conclusion drawn after the agency realized that food animals that have received antibiotics like penicillin end up acting as a “reservoir of antibiotic resistant pathogens and non-pathogens.” The agency knew, and stated, in 1977 that this situation could lead to antibiotic resistance and that it would potentially “produce human infections.”

The agency realized that the prevalence of new antibiotic-resistant bacteria was directly related to the “use of antibiotics and sulfonamide drugs” in food animals, and that there was a very real risk to human health if antibiotics are over-used in animal feed.

As evidence continued to mount that the use of antibiotics in meat production is leading to “superbugs” in humans that are more resistant to antibiotic treatments, the situation hit a melting point in May of 2011 when the Natural Resources Defense Council, the Center for Science in Public Interest, and other groups filed a lawsuit against the FDA to force it to take action based on the latest scientific information.

 

Meat industry practices lead to antibiotic resistance

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For over 35 years, the FDA has simply allowed the meat industry to self-regulate itself. The meat industry claims that antibiotics are critical to maintaining the health of its animals. One epidemiologist and assistant professor at West

Texas A&M University, Dr Guy Loneragan, stated at meat industry hearings on Capital Hill in 2010 that the use of antibiotics is critical: “Prompt and judicious use of efficacious antibiotics is critical for the successful treatment and, at times, control of specific bacterial diseases in cattle.

Certain FDA-approved antibiotics also enable us to significantly improve the efficiency of beef production.”

That phrase — “improve the efficiency of beef production” – is exactly what those critical of the industry say is the problem. Consumer and public health groups say that the meat industry isn’t only using antibiotics to treat herd diseases, they are using antibiotics in order to produce a greater amount of meat in a smaller space. By feeding low levels of antibiotics to herd animals over a long period, they can keep those animals in more cramped, unsanitary conditions without the animals contracting disease.

This is what Dr Loneragan calls, “…the efficiency of beef production.” However, a 2010 Pew Commission report confirmed the critic’s claims that the overuse of antibiotics is directly contributing to the rise of superbugs in humans. The report stated: “A key contributor to the rise of antibiotic-resistant bacteria is the overuse of drugs on industrial farms. Antibiotics important to human health are fed to food animals at low doses, often over long periods of time, creating a breeding ground for new and resistant bacteria and a potentially hazardous workplace.”

For many years, both industry scientists and consumer/health scientists have been battling over the science and the egitimacy of the other side’s scientific argument. The lawsuit filed in May of 2011 sent the battle to new heights, as the courts were brought into the discussion. The lawsuit was filed because the public health groups believe that scientific evidence is now strong enough to show that the FDA’s own warnings in 1977 have come true, and that the FDA is failing in its responsibility to protect the public health, instead cowing (pun intended) to industrial lobbyists.

Courts have the ability to force the FDA’s hand.

 

FDA tries to sidestep the lawsuit

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Surprising consumer and public health groups, the FDA attempted to sidestep the lawsuit by announcing in on 29 Dec 2011 that it would be withdrawing its long-standing plan to limit the use of antibiotics in animal feed. It stated that instead of

regulation, it would instead encourage “voluntary reform” within the agricultural industry rather than using enforcement. Public health critics said that the FDA had clearly timed the announcement during the holidays, and only announced it in a brief statement in the Federal Register, as an attempt to quietly change the rules without public fanfare.

The FDA attempt to sidestep the lawsuit didn’t work. On 22 Mar 2012 a federal judge ordered the FDA to begin working on withdrawing approval for the use of penicillin and tetracyclines in animal feed. The court went so far as to point out that the FDA should have carried out those actions once it discovered that antibiotics were potentially dangerous to human health in 1977.

The court order essentially serves as the last word in the long debate between industry scientists and public health scientists, stating that science falls squarely on the side of those interested in protecting the public health from antibiotic resistance. The court stated: “Research has shown that the use of antibiotics in livestock leads to the development of ntibiotic-resistant bacteria that can be – and has been — transferred from animals to humans through direct contact, environmental exposure, and the consumption and handling of contaminated meat and poultry products.” The lawsuit is good news to consumers, and more importantly to healthcare advocates that are concerned about the prevalence of superbugs throughout society — but the changes will not take effect immediately.

There will be a series of legal proceedings, and both the FDA and the highly-powerful agricultural industry may have a few tricks up their sleeves. The practice of “the efficiency of beef production” through crowded, unsanitary conditions goes right to the bottom line of the corporate meat industry, so they are not likely to give up without a fight.

[References and image credits are available at the source URL above:

1. International Business Times

2.Food Safety News

3.Natural Resources Defense Council

4.SFAW Newswire

5.Health FreedomAlliance

6.Wired.com

7. FDA

Notice of Opportunity for Hearing on Penicillin 1977]

Communicated by:

ProMED-mail from HealthMap Alerts

[email protected]

 

[2]

Date:

Fri 23 Mar 2012

Source:The New York Times [edited]

<fda-is-ordered-to-restrict-use-of-antibiotics-in-livestock.html>

Steps set for livestock antibiotic ban

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The Obama administration must warn drug makers that the government may soon ban agricultural uses of some popular antibiotics that many scientists say encourage the proliferation of dangerous infections and imperil public health, a federal magistrate judge ruled on Thursday [22 Mar 2012].

The order, issued by Judge Theodore H Katz of the Southern District of New York, effectively restarts a process that the Food and Drug Administration began 35 years ago, but never completed, intended to prevent penicillin and tetracycline, widely used antibiotics, from losing their effectiveness in humans because of their bulk use in animal feed to promote growth in chickens,pigs, and cattle.

The order comes 2 months after the Obama administration announced restrictions on agricultural uses of cephalosporins, a critical class of antibiotics that includes drugs like Cefzil [cefprozil] and Keflex [cephalexin], which are commonly used to reat pneumonia, strep throat, and skin and urinary tract infections.

Siobhan DeLancey, an FDA spokeswoman, would not say whether the government planned to appeal. “We are studying the opinion and considering appropriate next steps,” she said.

In a separate move, the FDA is expected to issue draft rules within days that ask drug makers to voluntarily end the use of antibiotics in animals without the oversight of a veterinarian.

But neither the judge’s order nor the FDA’s expected rule changes are likely to fundamentally alter the large-scale  agricultural uses of antibiotics becausefarmers and ranchers now say the drugs are being used to prevent animal diseases, not to promote growth. The FDA has so far refused to propose restrictions on antibiotic uses to prevent disease even when the drugs are delivered in feed or water, and Judge Katz’s order does not extend to disease prevention uses.

Gwen Venable, a spokeswoman for the US Poultry and Egg Association, said that poultry producers’ judiciously use  ntibiotics to maintain the health of their flocks.”

“Our association has not had an opportunity to review the judge’s order, so we cannot comment on the impact of the specific decision at this time,” she said.

Environmentalists and health advocates cheered Judge Katz’s ruling, as they have largely cheered the FDA’s incremental  efforts to begin restricting some of the less discriminating antibiotic agricultural uses because they welcome any improvement in the decades-old issue.

“The rise of superbugs that we see now was predicted by FDA in the ’70s,” said Jen Sorenson, a lawyer for the Natural Resources Defense Council.

But gricultural trade groups were more critical. Ron Phillips, vice president of public affairs for the Animal Health Institute, an association representing companies that make animal medicine, said that the judge’s order could slow efforts to reduce agricultural uses of antibiotics by diverting resources from the agency’s collaborative efforts with industry.

Antibiotics were the wonder drugs of the 20th century, and their initial uses in humans and animals were indiscriminate, experts say. Farmers were impressed by the effects of penicillin and tetracycline on the robustness of cattle, chickens, and pigs, and added the drugs to feed and water, with no prescriptions or sign of sickness in the animals.

By the 1970s, public health officials had become worried that overuse was leading to the development of killer infections resistant to treatment. In 1977, the FDA announced that it would begin banning some agricultural uses. But the House and

Senate appropriations committees passed resolutions against the ban, and the agency retreated.

“In the intervening years, the scientific evidence of the risks to human health from the widespread use of antibiotics in livestock has grown, and there is no evidence the FDA has changed its position that such uses are not shown to be

safe,” Judge Katz wrote in his order.

80 percent of antibiotics bought in the United States are used in animals, not humans. Meanwhile, outbreaks of illnesses from antibiotic-resistant bacteria have grown in number and severity, killing thousands.

Environmental and health groups petitioned the FDA in 1999 and 2005 to restart the process to ban the drugs for promoting animal growth. The Natural Resources Defense Council, the Center for Science in the Public Interest, the Food Animal Concerns Trust, Public Citizen, and the Union of Concerned Scientists filed suit against the FDA.

On Thursday [22 Mar 2012], Judge Katz ruled that these groups had won their case without need for a trial.

Judge Katz ordered the FDA to alert drug manufacturers that it intended to prohibit the use of penicillin and tetracycline to promote growth in animals. The manufacturers can request a hearing to present evidence that these uses are

safe. If the companies have such evidence, the drugs can continue to be used for growth promotion, the judge wrote.

[Byline: Gardiner Harris]

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Communicated

by:

ProMED-mail

Rapporteur Mary Marshall

[Both articles give slightly different information and a slightly different explanation of the situation.

What an interesting can of worms! It is a debate that seems to have escalated over the last decade and will likely get even hotter. While there is some evidence of antibiotic resistance, and no one wants to be the recipient of a disease that is resistant to our current forms of treatment, there is also evidence that animals get sick and need treatment.

The ruling is more based on long term feeding of antibiotics than on treatment of the animals. However without careful wording of ruling from anyone, it will be misinterpreted and then there will be widespread suffering of animals, which

will bring out the animal rights activists, the vegans and the vegetarians, and ultimately the outcome will be a sky rocketing of food prices, especially animal based proteins, and a public outcry.

While there may be need for a balance, the medical community (both human and veterinary) and the population as a whole are also responsible for resistant microbes. How many individuals have not taken the full amount of a prescription, but instead stopped it early, or saved it for later use? That practice encourages resistance of microbes. While the human medical professionals may find their hands tied in such situations, just as veterinarians face non-compliant clients who do similar actions with pets, it becomes the public’s responsibility to follow the prescription.

Sadly, many of the antibiotics given to people eventually find their way into the toilet, even though the pharmaceutical agent may be in a metabolized form, it may still be active. Eventually that water is recycled and supposedly purified and we consume it again. Only on the 2nd time or some multiple time around, it now has increasing levels of antibiotics in it. The same issue affects animals through the same water they consume, which is often from the same source as human drinking water. In many US communities there are disposal days for toxic substances such as paints, paint remover, etc, and  prescription medications. Many people, afraid someone will suspect them of some ailment, prefer to flush unused or out of date pharmaceutical agents down the toilet, and thus contribute to the antibiotic resistance issue.

So while the debate will rage for some time longer in animals, the demand on both sides of this argument will continue, and ultimately the price of food will rise and the resistant microbes will continue.